SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc.
SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc. (North Carolina): 510(k) cleared for Spinal Alignment Solutions, Inc. Its amount of 20 is below the median of 138 (1st percentile). Dated 35 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 20 · 1th percentile of 414 FDAPulse records · 0.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263172 |
| Device | SAS MIS Pelvic Incidence Rods |
| Applicant | Spinal Alignment Solutions, Inc. |
| Specialty / panel | Orthopedic |
| Product code | NKB |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-10 |
| Decision date | 2026-09-30 |
| Review time (days) | 20 |
| Third-party review | No |
| Applicant location | Wilmington, NC, US |
| amount percentile | 1th of 414 (median 138, 0.1x median) |
| Peer records CSV (9 NC records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc. and 9 North Carolina peers
- North Carolina FDAPulse records like this one: 9
- SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc.'s amount: 1st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 20-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 35 days ago.
What is the FDAPulse record for SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc. in North Carolina?
SAS MIS Pelvic Incidence Rods (K263172) by Spinal Alignment Solutions, Inc. was cleared on 2026-09-30 after 20 days of review.
How does SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc. compare to other North Carolina FDAPulse records?
Its amount of 20 is below the median (1th percentile); smaller records often move faster and face less competition. It is 35 days old, still within a typical 45-day follow-up window.
SAS MIS Pelvic Incidence Rods (K263172) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| SAS MIS Pelvic Incidence Rods (K263172) | NC | 2026-09-30 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
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- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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